Senior Global CMC Regulatory Lead

Pace Analytical Services, LLC

Downers Grove (IL)

Remote

USD 99,000 - 135,000

Full time

9 days ago

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Job summary

Pace Analytical Services, LLC in Downers Grove, IL seeks an experienced Regulatory Affairs leader for CMC submissions and global strategies. You will author and compile CMC sections for INDs, IMPDs, CTAs, amendments, and annual reports to ensure compliance and timely project progression.

The ideal candidate has 10+ years in CMC/regulatory affairs, strong technical writing, and the ability to coordinate with FDA, EMA, PMDA, and other authorities while guiding strategic decisions and process

Qualifications

BA/BS/MS/PhD in biochemistry, chemistry, biology or related field with 10+ years in CMC/regulatory affairs.
Hands-on experience authoring and compiling CMC sections for INDs, IMPDs, CTAs and related filings.
Strong knowledge of global CMC regulatory requirements (FDA, EMA, ICH).

Responsibilities

Regulatory Submissions: Author and compile CMC sections for regulatory applications (INDs, IMPDs, CTAs, amendments, annual reports).
Documentation: Draft and maintain CMC documents such as summaries, stability reports, and comparability protocols.
Communication: Support regulatory questions from FDA, EMA, PMDA and other authorities.
Strategy Implementation: Lead CMC regulatory strategies to support clinical trial initiation and progress.
Process Development: Develop templates, processes, and workflows for compliant CMC operations.
Other duties as assigned.